Z-1110-2017Class II

RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures

Name: Z-1110-2017 RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures
Creator: Biom'up
Published: 2016-12-02
License: https://open.fda.gov/license/

Dilon Technologies France SAS / initiated 2016-12-02 / Terminated / root cause: manufacturing process

FDA source

Biom'up began a recall of RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures on 2016-12-02. FDA classified it as Class II and gives the reason as "Lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1110-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Posted: 2017-01-27
Terminated: 2017-05-05
Recalling firm: Dilon Technologies France SAS
Product: RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Product code: NPL Barrier, Animal Source, Intraoral
Reason for recall: Lack of sterility assurance
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Recall letter was mailed to affected customer on 12/02/2016 to inform them of the recall. The reason and actions to be taken were explained in the letter. Customer was asked to examine their inventory and contact Biom'Up to arrange for return of product.
Quantity in commerce: 1,682 units
Distribution: Distributed to a sole distributor in NC.
Product codes and lots: Lot Numbers: MCG16003.133034 MCG16003.133035 MCG16003.133036 MCG16003.133037 MCG16003.133038 MCG16003.133172 MCG16003.133173 MCG16003.133174 MCG16003.133251 MCG16003.133252 MCG16003.133253 MCG16003.133254

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1110-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1110-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-27

Product code NPL

K103087Class IICovamax Resorbable Collagen MembraneBiom'Up Sas / cleared 2011-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)